FMS OMNICUT 287432Recalls & reported problems
Depuy Mitek, LLC · FMS OMNICUT Resection Blade 4.2mm SOFT TISSUE and BONE SHAVER BLADE FOR USE with FMS DUO System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705022496), received between Jul 22, 2019 and Aug 30, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Fragmentation2
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2019Material Fragmentation; Material Fragmentation
DEVICE REPORT FROM MITEK (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE OMNICUT 4.2 RES BLADE 5PK DUO+ HAD METAL ABRASION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED FRAGMENTS WERE GENERATED BUT IT IS UNKNOWN IF OR HOW THEY WERE REMOVED. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8950069 ↗MalfunctionAug 30, 2019Material Fragmentation; Material Fragmentation
DEVICE REPORT FROM MITEK (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE OMNICUT 4.2 RES BLADE 5PK DUO+ HAD METAL ABRASION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED FRAGMENTS WERE GENERATED BUT IT IS UNKNOWN IF OR HOW THEY WERE REMOVED. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8950036 ↗MalfunctionJul 22, 2019Peeled/Delaminated; Peeled/Delaminated
9/3/2019: UPDATE: IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. FRAGMENTS WERE GENERATED AND THERE IS NO DEFINITIVE INDICATION THAT FRAGMENTS WERE RETAINED IN THE PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE REASSESSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8813426 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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